BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    MDR report key: 25075352 · Received May 4, 2026

    Report

    Report Number
    2032282-2026-00102
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Report Date
    May 4, 2026
    Manufacturer
    TAKEDA PHARMACEUTICALS U.S.A., INC.,
    Product Code
    LHI
    PMA / PMN Number
    K092318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS SUBMITTED FOLLOWING A RETROSPECTIVE COMPLAINT REVIEW CONDUCTED UNDER CAPA: PR 5560509. THE EVENT MET MDR REPORTABILITY CRITERIA BUT WAS NOT REPORTED WITHIN THE REQUIRED TIMEFRAME DUE TO AN INITIAL MISASSESSMENT OF REPORTABILITY. THIS REPORT IS BEING SUBMITTED UPON IDENTIFICATION OF THE REPORTING GAP AND CONFIRMATION OF REPORTABILITY. NO COMPLAINT SAMPLE WAS MADE AVAILABLE. TWENTY (20) RETENTION SAMPLES FROM FEIBA LOT: F2B014AA, EIGHTY-TWO (82) RETENTION SAMPLES FROM SWFI LOT: L000533 AND ONE (1) RETENTION SAMPLE OF THE BAXJECT DEVICE (LOT: GR354103) PACKED TO LOT: F2B014AA WERE OPTICALLY INSPECTED. A LIGHTHOUSE TEST OF ONE (1) RETENTION SAMPLE (B)(6) WAS ALSO PERFORMED. THE INSPECTED SAMPLES WERE COMPLIANT WITH THE REQUIREMENTS; NO ABNORMALITIES WERE OBSERVED. REVIEW OF INCOMING GOOD RELEASE DOCUMENTATION OF BATCH: GR354103 SHOWED THAT THERE WERE NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT CONTRIBUTED TO THE REPORTED PROBLEM. NO ROOT CAUSE WAS IDENTIFIED, NO CORRECTIVE AND / OR PREVENTIVE ACTIONS WERE APPLICABLE. THE COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE MONTHLY REPORT (NOVEMBER 2024) FOR FEIBA WAS ALSO PERFORMED RELATIVE TO THE SUBCATEGORY "RECONSTITUTION DIFFICULTY". THE COMPLAINT RATE FOR YTD2024 IS APPROXIMATELY (B)(4) COMPARED TO 2022 (B)(4) AND 2023 (B)(4).

    Description of Event or Problem · 0

    THE COMPLAINT STATES, "WE HAD A CUSTOMER REPORTING 1 VIAL OF FEIBA THAT DID NOT DRAW THE DILUENT INTO THE VIAL WHEN ATTACHED WITH THE CONNECTOR." "WHEN THE TECHNICIAN WAS MIXING THE VIAL, THEY ATTACHED THE CONNECTOR TO THE DILUENT 1ST AND THEN TO THE DRUG VIAL, BUT IT DID NOT DRAW THE DILUENT IN. THE CUSTOMER CURRENTLY HAS THE VIAL AND BOX PLEASE LET ME KNOW IF YOU NEED ADDITIONAL INFORMATION AND WHAT THE NEXT STEPS ARE." BIOCARE IS NOT REQUESTING A REPLACEMENT AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416095 BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE Set, i.V. Fluid transfer LHI TAKEDA PHARMACEUTICALS U.S.A., INC.,

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown